Adolescents ObesityNCT05694143
the Effectiveness of Health Literacy Intervention Among Middle Eastern Adolescents in Malaysia
A study testing Education Intervention in people with Adolescents Obesity, run by University of Malaya at 1 site in Malaysia.
Trial summary
In Malaysia, Middle Eastern adolescents are going through changes in living status, yet few studies show that overweight and obesity are prevalent among Arabic secondary school students. There have not been any intervention studies among Middle Eastern adolescents in Malaysia. Read more about this study
- Who is it for?
- Ages 13 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescents Obesity
- What is being tested?
- Education Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2023to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Arabic citizen students
- Aged 13 to 14 years
- Who at least one of their parents consented to participate in the study.
Who cannot join
- Students with diseases such as asthma, diabetes, cancer, cardiovascular diseases, fractures, cirrhosis, or other diseases.
- Students with any medical condition who are not allowed to do physical activity.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Hanan Al-haroni
Kuala Lumpur, Selangor, 53300
Hanan Al-haroni, 0060172855427, alharonihanan@gmail.com
Nik Daliana Nik Farid, 0060122779250, daliana@ummc.edu.my
About this study
Official title: The Effectiveness Of Health Literacy Intervention On Physical Activity And Healthy Diet Among Middle Eastern Adolescents In Malaysia
In Malaysia, Middle Eastern adolescents are going through changes in living status, yet few studies show that overweight and obesity are prevalent among Arabic secondary school students. There have not been any intervention studies among Middle Eastern adolescents in Malaysia. The current study aims to determine the effects of an intervention program on physical activity and healthy diet behavior among Middle Eastern adolescent students in Arabic schools in Malaysia
Read the detailed description
A cluster randomized controlled study will be conducted among 250 Middle Eastern adolescent students in Arabic schools in Malaysia. The intervention and control schools will be selected and allocated randomly. The intervention group will have six weeks of fortnightly six sessions (45 minutes), while the control group will have their regular curriculums and normal physical activity routine. Anthropometric questionnaires include knowledge, attitude, and practice of lifestyle, physical activity, adolescent sedentary activity, food assessment, and health belief model questionnaire. Data will be collected from intervention and control groups at baseline, post-intervention, and tow month follow-up after the intervention. Data will be analyzed by using the (SPSS) software version 25. Descriptive statistics will be used to distribute and summarize the data. The normality of variables will be tested by The Kolmogorov-Smirnov test and the Skewness \& Kurtosis test. A P-value < 0.05 will be considered statistically significant. One Way ANOVA will be used to determine whether any significant within group differences existed over time for the selected variables if the data is normally distributed, while Friedman's test will be used if the data is not normally distributed. Generalized Estimating Equation (GEE) will be used to test the effect of the intervention program for the selected variables (outcomes) between \& within-group at baseline, six weeks, and one month after intervention which is adjusted for clustering
- Conditions
- Adolescents Obesity
- Being tested
- Education Intervention, No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education InterventionOther
This intervention is based on the Health Belief Model Theory, which examines the attitudes and beliefs of adolescents with enhanced knowledge and perceived disease risk. As a result, It aims to build on adolescents' skills and behaviours rather than increase their knowledge, beliefs, and relative skills. In order to develop the education program, health promotion experts with a special interest in changing obesity-related behaviours will assist the researcher.
The intervention is specifically designed to help adolescents:
- To know facts, statistics and harmful effects of obesity and overweight.
- To know facts about physical activity and its importance.
- To know facts about a healthy diet and its importance.
- Definition of BMI and calculating the BMI.
- To read the Nutrition Facts label.
- To develop decision-making and self-care education.
No InterventionOther
They will have their regular curriculums and normal physical activity routine
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | Intervention group: Participants assigned to the intervention group will receive both will receive educational intervention including educational booklet will be distributed to the participants in the first session, and they will be asked to take it home and read it within one week. The booklet's content will include the risk factors of NCD and the benefits of adopting a healthy diet and physical activity in reducing overweight and obesity. Then, the educational classes will include six weekly teaching units. The general objective is to prevent obesity among students by delivering education and behavioural skills. The training units will be carried out in the schools. Each training unit will end with activities. The adolescents will learn more about their susceptibility to obesity and weight gain and how to make better decisions and feel better about themselves through these activities. Receives: Other: Education Intervention |
| Control group: No Intervention | Other | Participants randomized to the control group in this study will not receive any intervention (They will have their regular curriculums and normal physical activity routine). Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Knowledge, Attitude and Practice of Nutrition and Physical Activity.
The Knowledge, Attitude, and Practice of Nutrition and Physical Activity will be measured using a self-report instrument Knowledge, Attitude, and Practice of Nutrition and Physical Activity Questionnaire (KAP-Q). The questionnaire consists of 73 items: knowledge (30), attitude (22), and practice (21). The presented knowledge part consists of 30 items to determine participants' knowledge level on Nutrition and Physical Activity. There are multiple-choice questions ell be each choice has "True", "False", and "I do not know" response options. Having a score above the mean means good knowledge. In the attitude section, there are 22 items with five Likert scales for assessing the attitude. A more positive attitude has higher scores. Practice includes 21 questions with five Likert scales for assessing the practice. A higher score shows more positive practice.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Change Physical Activity of the adolescent.
The Physical Activity will be measured using a self-report instrument Physical Activity Questionnaire for Older Children (PAQ-C). PAQ-C gives an overview of physical activity levels among participants of this study because PAQ-C is suitable for school children (8-14 years of age). PAQ-C has ten items. Each of the 9 PAQ-C questionnaire items is scored from 1 (low physical activity) to 5 (high physical activity), and a mean score of all items constitutes the overall PAQ-C score.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Secondary outcomes (4)
Change Sedentary Activity of the adolescent.
Sedentary Activity will be measured by using a self-report instrument the Adolescent Sedentary Activity Questionnaire (ASAQ). The questionnaire will ask the participants how many hours and minutes they spent in eleven different sedentary behaviours per day on weekdays and weekends. The questionnaire classified the eleven sedentary behaviours into five categories (Screen time, education, travel, cultural activities and social activities). Participants indicate high sedentary behaviour if the total time of (ASAQ) ≥ 4 hrs/day, while < 4 hrs/day means low sedentary behaviour.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Change frequency of consumption of food.
The frequency of consumption of food will be measured by using a self-report instrument Semi-Quantitative Food-Frequency Questionnaire (SFFQ). The SFFQ contains 74 food items among adolescents in the Arab region. The category of frequency intake is once per day, 2-3 per day, 4-5 per day, 6-7 times per day, 1-2 weeks, 3-4 per week, 5-6 per week, once a month, 2-3 monthly, or never. The 74 items of nutrients and food groups' reproducibility rates were 0.46 and 0.49, respectively. Participants will ask about the food that they consumed. Also, they will define the time and the quantity of the food.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Change Health Belief
The Health Belief will be measured by using a self-report instrument Health Belief Questionnaire (HBQ). There will be 89 statements total, representing 8 perceptional and behavioural categories including severity perception, perceived barriers, perceived benefits, action cues, dietary self-efficacy, exercise self-efficacy, and weight management behavioural intention. All statements were rated using a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). A higher score indicates a greater level of belief.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Change the Body mass index (BMI).
The Body mass index (BMI) will be report in kg/m^2 by using the following formula (BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared). Body weight will be measured using Omron HBF 375 to the nearest 0.1 kg. SECA body meter 206 will be employed to measure their heights to the nearest 0.1 cm. Body mass index (BMI) will be classified into (underweight, normal weight, overweight, and obesity). If the BMI is less than 18.5, it falls within the underweight range. If the BMI is 18.5 to <25, it falls within the healthy weight range. If the BMI is 25.0 to <30, it falls within the overweight range. If the BMI is 30.0 or higher, it falls within the obesity range. In addition, the Body mass index (BMI)-for-age (z-score) will be analysed using WHO AnthroPlus version 1.0.4 software and the WHO Growth Reference was used to categorise their body weight status using the reference data for children and adolescents aged 5-19 years.
Measured: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Jan 2023
- Primary completionMay 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescents ObesityStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- A cluster randomized controlled trial design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694143
- Sponsor's protocol ID
- UM-PhD Hanan
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Haroni H, Nik Farid ND, Azanan MS. Effectiveness of education intervention, with regards to physical activity level and a healthy diet, among Middle Eastern adolescents in Malaysia: A study protocol for a randomized control trial, based on a health belief model. PLoS One. 2024 Jan 17;19(1):e0289937. doi: 10.1371/journal.pone.0289937. eCollection 2024.
PubMed 38232100
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness Of Health Literacy Intervention On Physical Activity And Healthy Diet Among Middle Eastern Adolescents In Malaysia
- ClinicalTrials.gov ID
- NCT05694143
- Acronym / sponsor ID
- UM-PhD Hanan
- Conditions
- Adolescents Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Malaysia, Middle Eastern adolescents are going through changes in living status, yet few studies show that overweight and obesity are prevalent among Arabic secondary school students. There have not been any intervention studies among Middle Eastern adolescents in Malaysia. The current study aims to determine the effects of an intervention program on physical activity and healthy diet behavior among Middle Eastern adolescent students in Arabic schools in Malaysia
Detailed description
A cluster randomized controlled study will be conducted among 250 Middle Eastern adolescent students in Arabic schools in Malaysia. The intervention and control schools will be selected and allocated randomly. The intervention group will have six weeks of fortnightly six sessions (45 minutes), while the control group will have their regular curriculums and normal physical activity routine. Anthropometric questionnaires include knowledge, attitude, and practice of lifestyle, physical activity, adolescent sedentary activity, food assessment, and health belief model questionnaire. Data will be collected from intervention and control groups at baseline, post-intervention, and tow month follow-up after the intervention. Data will be analyzed by using the (SPSS) software version 25. Descriptive statistics will be used to distribute and summarize the data. The normality of variables will be tested by The Kolmogorov-Smirnov test and the Skewness \& Kurtosis test. A P-value < 0.05 will be considered statistically significant. One Way ANOVA will be used to determine whether any significant within group differences existed over time for the selected variables if the data is normally distributed, while Friedman's test will be used if the data is not normally distributed. Generalized Estimating Equation (GEE) will be used to test the effect of the intervention program for the selected variables (outcomes) between \& within-group at baseline, six weeks, and one month after intervention which is adjusted for clustering
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A cluster randomized controlled trial design
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: Education InterventionIntervention group: Participants assigned to the intervention group will receive both will receive educational intervention including educational booklet will be distributed to the participants in the first session, and they will be asked to take it home and read it within one week. The booklet's content will include the risk factors of NCD and the benefits of adopting a healthy diet and physical activity in reducing overweight and obesity. Then, the educational classes will include six weekly teaching units. The general objective is to prevent obesity among students by delivering education and behavioural skills. The training units will be carried out in the schools. Each training unit will end with activities. The adolescents will learn more about their susceptibility to obesity and weight gain and how to make better decisions and feel better about themselves through these activities. |
| Control group: No Intervention | Other | Other: No InterventionParticipants randomized to the control group in this study will not receive any intervention (They will have their regular curriculums and normal physical activity routine). |
Who may qualify
- Ages
- 13 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Arabic citizen students
- Aged 13 to 14 years
- Who at least one of their parents consented to participate in the study.
Key exclusion criteria (2 listed)
- Students with diseases such as asthma, diabetes, cancer, cardiovascular diseases, fractures, cirrhosis, or other diseases.
- Students with any medical condition who are not allowed to do physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education InterventionThis intervention is based on the Health Belief Model Theory, which examines the attitudes and beliefs of adolescents with enhanced knowledge and perceived disease risk. As a result, It aims to build on adolescents' skills and behaviours rather than increase their knowledge, beliefs, and relative skills. In order to develop the education program, health promotion experts with a special interest in changing obesity-related behaviours will assist the researcher. The intervention is specifically designed to help adolescents: * To know facts, statistics and harmful effects of obesity and overweight. * To know facts about physical activity and its importance. * To know facts about a healthy diet and its importance. * Definition of BMI and calculating the BMI. * To read the Nutrition Facts label. * To develop decision-making and self-care education. | Other | Intervention group |
| No InterventionThey will have their regular curriculums and normal physical activity routine | Other | Control group: No Intervention |
Primary outcome
Change Knowledge, Attitude and Practice of Nutrition and Physical Activity.
Time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
The Knowledge, Attitude, and Practice of Nutrition and Physical Activity will be measured using a self-report instrument Knowledge, Attitude, and Practice of Nutrition and Physical Activity Questionnaire (KAP-Q). The questionnaire consists of 73 items: knowledge (30), attitude (22), and practice (21). The presented knowledge part consists of 30 items to determine participants' knowledge level on Nutrition and Physical Activity. There are multiple-choice questions ell be each choice has "True", "False", and "I do not know" response options. Having a score above the mean means good knowledge. In the attitude section, there are 22 items with five Likert scales for assessing the attitude. A more positive attitude has higher scores. Practice includes 21 questions with five Likert scales for assessing the practice. A higher score shows more positive practice.
Change Physical Activity of the adolescent.
Time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
The Physical Activity will be measured using a self-report instrument Physical Activity Questionnaire for Older Children (PAQ-C). PAQ-C gives an overview of physical activity levels among participants of this study because PAQ-C is suitable for school children (8-14 years of age). PAQ-C has ten items. Each of the 9 PAQ-C questionnaire items is scored from 1 (low physical activity) to 5 (high physical activity), and a mean score of all items constitutes the overall PAQ-C score.
4 secondary outcomes
Change Sedentary Activity of the adolescent.
Time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Change frequency of consumption of food.
Time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Change Health Belief
Time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Change the Body mass index (BMI).
Time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Derived from this study: PubMed 38232100Al-Haroni H, Nik Farid ND, Azanan MS. Effectiveness of education intervention, with regards to physical activity level and a healthy diet, among Middle Eastern adolescents in Malaysia: A study protocol for a randomized control trial, based on a health belief model. PLoS One. 2024 Jan 17;19(1):e0289937. doi: 10.1371/journal.pone.0289937. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Intervention in people with Adolescents Obesity, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanan Al-haroni (0172855427, alharonihanan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Knowledge, Attitude and Practice of Nutrition and Physical Activity. (time frame: [Time Frame: Timepoint 1 = Baseline. Repeated measurement: Timepoint 2 = week 12 (Five-week post-intervention)]]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05694143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.